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Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer (SCV-07 OM)

Primary Purpose

Oral Mucositis, Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
SCV-07
SCV-07
Sponsored by
SciClone Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Oral Mucositis focused on measuring SCV-07, Oral Mucositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject must have a body weight less than 150 kg at screening
  • Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is < 6 weeks prior to initiation of radiotherapy.
  • Plan to receive a continuous course of conventional external beam irradiation
  • Plan to receive a standard cisplatin chemotherapy regimen

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor
  • Prior radiation to the head and neck
  • Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy
  • Had curative surgery more than 6 weeks prior to the initiation of radiotherapy
  • Have current oral mucositis
  • Presence of active infectious disease excluding oral candidiasis
  • Chronic immunosuppression
  • Seropositive for HIV or hepatitis B surface antigen or C antibody
  • Used an investigational agent within 30 days of randomization
  • Have a known sensitivity to any investigational agent

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Oncology Services Foundation
  • University of Arkansas for Medical Sciences
  • Whittingham Cancer Center
  • Helen F Graham Cancer Center
  • University of Illinois at Chicago
  • James Graham Brown Cancer Center
  • Karmanos Cancer Institute
  • Washington University in St Louis
  • The Nebraska Medical Center
  • Montefiore Medical Center
  • Beth Israel Medical Center
  • Carolinas Medical Center
  • Mid Dakota Clinic
  • Ohio State University Medical Center
  • St Luke's Hospital & Health Network
  • Temple University
  • Vanderbilt-Ingram Cancer Center
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Placebo

SCV-07 at a dose of 0.02 mg/kg

SCV-07 at a dose of 0.10 mg/kg

Outcomes

Primary Outcome Measures

Safety will be assessed by collecting and recording AEs and laboratory assessments. Labs will be collected at screening,weekly throughout the subject's RT treatment and on the last day of radiotherapy.
Efficacy of Oral Mucositis assessment will be completed by trained site personnel. The WHO score will be the primary measure and NCI CTCAE will be a secondary measure for assessing Oral Mucositis.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2008
Last Updated
November 20, 2009
Sponsor
SciClone Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00756951
Brief Title
Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer
Acronym
SCV-07 OM
Official Title
A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SC-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
SciClone Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer. The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis, Head and Neck Cancer
Keywords
SCV-07, Oral Mucositis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
SCV-07 at a dose of 0.02 mg/kg
Arm Title
3
Arm Type
Active Comparator
Arm Description
SCV-07 at a dose of 0.10 mg/kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SCV-07
Intervention Description
0.02 mg/kg
Intervention Type
Drug
Intervention Name(s)
SCV-07
Intervention Description
0.10 mg/kg
Primary Outcome Measure Information:
Title
Safety will be assessed by collecting and recording AEs and laboratory assessments. Labs will be collected at screening,weekly throughout the subject's RT treatment and on the last day of radiotherapy.
Time Frame
7 Weeks
Title
Efficacy of Oral Mucositis assessment will be completed by trained site personnel. The WHO score will be the primary measure and NCI CTCAE will be a secondary measure for assessing Oral Mucositis.
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must have a body weight less than 150 kg at screening Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is < 6 weeks prior to initiation of radiotherapy. Plan to receive a continuous course of conventional external beam irradiation Plan to receive a standard cisplatin chemotherapy regimen Exclusion Criteria: Pregnant or breastfeeding Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor Prior radiation to the head and neck Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy Had curative surgery more than 6 weeks prior to the initiation of radiotherapy Have current oral mucositis Presence of active infectious disease excluding oral candidiasis Chronic immunosuppression Seropositive for HIV or hepatitis B surface antigen or C antibody Used an investigational agent within 30 days of randomization Have a known sensitivity to any investigational agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Israel Rios, MD
Organizational Affiliation
SciClone Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Oncology Services Foundation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Whittingham Cancer Center
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Lousiville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University in St Louis
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Mid Dakota Clinic
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbis
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
St Luke's Hospital & Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.sciclone.com
Description
Related Info

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Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer

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